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Extended-Field Irradiation and Intracavitary Brachytherapy Combined With Cisplatin Chemotherapy for Cervical Cancer With Positive Para-Aortic or High Common Iliac Lymph Nodes: Results of ARM 1 of RTOG 0116

Journal Article · · International Journal of Radiation Oncology, Biology and Physics
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8];  [9]
  1. Department of Radiation Oncology, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (United States)
  2. RTOG Statistical Section, Philadelphia, PA (United States)
  3. Department of Gynecologic Oncology, M. D. Anderson Cancer Center, Houston, TX (United States)
  4. Department of Radiology, M. D. Anderson Cancer Center, Houston, TX (United States)
  5. Department of Radiation Oncology, University of Utah, Salt Lake City, UT (United States)
  6. Department of Radiation Oncology, Albert Einstein Medical Center, Philadelphia, PA (United States)
  7. Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States)
  8. Department of Radiation Oncology, M. D. Anderson Cancer Center, Houston, TX (United States)
  9. Department of Radiation Oncology, Wake Forest University, Winston Salem, NC (United States)
Purpose: The Radiation Therapy Oncolology Group (RTOG) 0116 trial was designed to test the ability of Amifostine to reduce the toxicity of combined chemotherapy with extended-field radiotherapy and brachytherapy (Part 2), after first determining the toxicity rate for the regimen without Amifostine (Part 1). This manuscript reports the results of Part 1. Methods and Materials: Eligibility included patients with cervical carcinoma and high common iliac or para-aortic metastasis. Patients received extended-field radiotherapy to 45 Gy (1.8 Gy/fraction) with intracavitary irradiation. The final point A dose was 85 Gy LDR equivalent. Use of HDR was allowed. The positive para-aortic and high common iliac nodes were boosted to 54 to 59.4 Gy. Cisplatin (40 mg/m{sup 2}) was delivered weekly during external beam and once with brachytherapy. The primary endpoint of Part 1 was acute Grade 3/4 toxicity, excluding Grade 3 leukopenia. Results: A total of 26 eligible patients were entered between August 1, 2000, and Decemeber 3, 2003. Of these, 21 had para-aortic metastasis (15 also had high common iliac involvement), and 5 had high common iliac involvement only. The median follow-up was 17.1 months (range, 1.8-38.6 months) for all patients and 21.7 months (range, 11.4-38.6 months) for alive patients. The acute Grade 3/4 toxicity rate, excluding Grade 3 leukopenia was 81%. Late Grade 3/4 toxicity was 40%. Eight patients underwent surgery for complications. Sixteen (62%) patients had a complete response for both local and nodal disease. The complete local response was 92%, the complete overall nodal response rate was 62% and the regional and para-aortic nodal response rates were 60% and 71% respectively. Estimated disease-free and overall survival at 18 months are 46% and 60%. Conclusions: Extended field and intracavitary irradiation with cisplatin for para-aortic or high common iliac metastasis from cervical cancer is associated with significant acute and late toxicity.
OSTI ID:
20953559
Journal Information:
International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 4 Vol. 68; ISSN IOBPD3; ISSN 0360-3016
Country of Publication:
United States
Language:
English

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